NEW MEDICAL DEVICE QUESTION

I'm a senior electrical engineering student working my senior design project which is a portable battery-powered medical device which uses LEDs to shine light with a specific wave length on oral cancer cells to kill them. A senior team from 2 years ago worked on this project and made a prototype, however I don't think they ever considered building a prototype with medical standards in mind. That is what I would like to do, but I'm not sure how to go about figuring out what medical standards are required. How and where would I begin to look this up?

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Good morning,

I work for EirMed, a contract manufacturing company located in Menomonie, WI. EirMed is a leader in the design, engineering, manufacturing, assembly and packaging of medical devices. Our expertise is integrated into the creation of devices designed to improve patients’ lives. Our diverse experience and knowledge enables the development and manufacturing of advanced medical devices, with an array of capabilities.

EirMed is ISO 13485 and ISO 9001 certified and has the experience and expertise to not only assist you with building a prototype that considers medical device standards, but can also provide assistance through all phases of your project- development, validation, and production. Check out our website at: https://eirmed-devices.com/. If you are interested in learning more, I can be reached at (715)235-1464, ask for Brittany.

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